Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001421325p
Ethics application status
Submitted, not yet approved
Date submitted
26/09/2017
Date registered
9/10/2017
Date last updated
9/10/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison of different post-opervative local anaesthetic infusion locations on recovery after total knee replacement surgery
Scientific title
A multicentre trial of Continuous Catheters in Adductor Canal versus Femoral Triangle (The CAFE Study) locations for Total Knee Replacement Surgery
Secondary ID [1] 292976 0
Nil known
Universal Trial Number (UTN)
U1111-1202-7574
Trial acronym
The CAFE study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Joint replacement 304877 0
Adductor canal block 304878 0
Condition category
Condition code
Anaesthesiology 304189 304189 0 0
Anaesthetics
Musculoskeletal 304190 304190 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A Continuous femoral triangle block will be undertaken. An experienced regional anaesthetist will perform this procedure in the operating theatre immediately following the total knee replacement surgery. This is a single procedure, undertaken under local anaesthesia, where a small catheter is positioned under ultrasound guidance to lie adjacent to the femoral nerve branches in the mid-thigh (the level of the femoral triangle is identified by visualisation of the anatomical relationships of the thigh muscles - 5cm PROXIMAL to where the medial border of adductor longus muscle crossed the medial border of the sartorius muscle) . This catheter will be attached to a local anaesthetic pain pump for ongoing administration of local anaesthetic in the days following the procedure - 0.5% ropivacaine at 6mL per hour via an ambulatory AmbIT pump (Admedus Australia) for 3 days. All patients will undertake written informed consent before the procedure, including receiving written patient information.
Intervention code [1] 299216 0
Treatment: Other
Comparator / control treatment
A Continuous adductor canal block will be undertaken. An experienced regional anaesthetist will perform this procedure in the operating theatre immediately following the total knee replacement surgery. This is a single procedure, undertaken under local anaesthesia, where a small catheter is positioned under ultrasound guidance to lie adjacent to the femoral nerve branches in the mid-thigh (the level of the adductor canal is identified by visualisation of the anatomical relationships of the thigh muscles - 5cm DISTAL to where the medial border of adductor longus muscle crossed the medial border of the sartorius muscle) . This catheter will be attached to a local anaesthetic pain pump for ongoing administration of local anaesthetic in the days following the procedure - 0.5% ropivacaine at 6mL per hour via an ambulatory AmbIT pump (Admedus Australia) for 3 days. All patients will undertake written informed consent before the procedure, including receiving written patient information.
Control group
Active

Outcomes
Primary outcome [1] 303500 0
Timed-Up-And-Go-Test
Timepoint [1] 303500 0
Post-operative day 1 (22-26 hours)
Secondary outcome [1] 339080 0
Timed-Up-And-Go-Test
Timepoint [1] 339080 0
Post-operative day 2
Secondary outcome [2] 339081 0
Pain scores - VAS scores rating on a 10 point scale
Timepoint [2] 339081 0
Post operative day 1 and 2
Secondary outcome [3] 339082 0
Opiate use in oral morphine equivalents (review of medication chart)
Timepoint [3] 339082 0
Post operative day 1 and 2

Eligibility
Key inclusion criteria
Adults, aged > 18 years old, not pregnant
Admitted for elective, primary, unilateral, total knee replacement
Mentally competent to provide informed own written consent in English
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Previous total knee replacement surgery to same knee
2. Bilateral knee replacement surgery
3. previously enrolled in study
4. Chronic opioid use; defined as > 20mg oral morphine equivalent per day on average, in the 4 weeks prior to surgery

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer software generated randomised allocation sequence
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The primary outcome of TUG time between the FTC and ACC groups at POD1 will be analysed using t-tests. Secondary outcomes will be analysed using t-tests, Mann-Whitney U tests, and repeated measures ANOVA. Analysis will use two tailed p < 0.05 for statistical significance.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2018
Actual
Date of last participant enrolment
Anticipated
28/06/2018
Actual
Date of last data collection
Anticipated
30/06/2018
Actual
Sample size
Target
140
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,WA
Recruitment hospital [1] 9105 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 9106 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [3] 9107 0
Joondalup Health Campus - Joondalup
Recruitment postcode(s) [1] 17605 0
2050 - Camperdown
Recruitment postcode(s) [2] 17606 0
6009 - Nedlands
Recruitment postcode(s) [3] 17607 0
6027 - Joondalup
Recruitment outside Australia
Country [1] 9234 0
New Zealand
State/province [1] 9234 0
Waikato
Country [2] 9235 0
United States of America
State/province [2] 9235 0
Washington

Funding & Sponsors
Funding source category [1] 297602 0
Hospital
Name [1] 297602 0
Royal Prince Alfred Hospital
Country [1] 297602 0
Australia
Primary sponsor type
Hospital
Name
Royal Princa Alfred Hospital
Address
Missenden Road
Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 296616 0
None
Name [1] 296616 0
Address [1] 296616 0
Country [1] 296616 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 298695 0
Sydney Local Health District Ethics Review Committee (ERC
Ethics committee address [1] 298695 0
Ethics committee country [1] 298695 0
Australia
Date submitted for ethics approval [1] 298695 0
28/08/2017
Approval date [1] 298695 0
Ethics approval number [1] 298695 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 77918 0
A/Prof Alwin Chuan
Address 77918 0
Department of Anaesthesia
Liverpool Hospital
Liverpool. NSW. 2170
Country 77918 0
Australia
Phone 77918 0
+61 407743668
Fax 77918 0
Email 77918 0
[email protected]
Contact person for public queries
Name 77919 0
Alwin Chuan
Address 77919 0
Department of Anaesthesia
Liverpool Hospital
Liverpool. NSW. 2170
Country 77919 0
Australia
Phone 77919 0
+61 407743668
Fax 77919 0
Email 77919 0
[email protected]
Contact person for scientific queries
Name 77920 0
Alwin Chuan
Address 77920 0
Department of Anaesthesia
Liverpool Hospital
Liverpool. NSW. 2170
Country 77920 0
Australia
Phone 77920 0
+61 407743668
Fax 77920 0
Email 77920 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.